Systems, methods and devices for removing obstructions from a blood vessel

ABSTRACT

Devices and methods for removing an obstruction from a blood vessel are described. The devices are deployed in a collapsed condition and are then expanded within the body. The devices are then manipulated to engage and remove the obstruction.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of application Ser.No. 09/891,141, filed Jun. 25, 2001, which is a continuation in part ofSer. No. 09/756,476, filed Jan. 8, 2001, which is a continuation-in-partof application Ser. No. 09/605,143, filed Jun. 29, 2000, the fulldisclosures of which are incorporated herein by reference for allpurposes.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention is directed to methods and devices for removingobstructions from blood vessels. The device may be used to retrieve andremove clots and other biological obstructions. The device may also beused to retrieve embolic coils and the like which have been misplaced orhave migrated to an undesirable location.

One such obstruction removal device is disclosed in U.S. Pat. No.5,895,398 which is hereby incorporated by reference. The device has anexpandable engaging member which is introduced into the blood vessel toengage the obstruction for removal.

The present invention is also directed to devices, systems and methodswhich use an expandable capture element when removing obstructions froma blood vessel. One such system for removing obstructions in a bloodvessel is described in U.S. Pat. No. 5,102,415 to Guenther et al. Thesystem described in U.S. Pat. No. 5,102,415 has a balloon catheter and acatheter having an expandable tip which receives the obstruction. Theballoon catheter is passed through the obstruction while the balloon isdeflated. The balloon is then inflated and the tip of the catheter isexpanded. The balloon is then moved proximally so that the obstructionis pulled into the expanded tip of the catheter. A problem with thesystem of U.S. Pat. No. 5,102,415 is that the interaction between theballoon catheter and the leading edge of the catheter may tend to shearoff portions of the obstruction. This can cause obvious problems whenworking in sensitive vascular areas.

The present invention is directed to additional devices and methods forremoving obstructions in a blood vessel.

SUMMARY OF THE INVENTION

In accordance with the present invention, device and methods forremoving obstructions are provided. In a first aspect of the invention,an obstruction removal device is provided which has an obstructionengaging element extending from an insertion element. The engagingelement is movable from a collapsed position to an expanded position.The engaging element forms coils having varying diameter wherein thecoils at a distal portion are larger than coils at an intermediateportion. The distal portion forms a relatively closed structure whichprevents the obstruction, or any part thereof, from migratingdownstream. The distal portion is expanded distal to the obstructionwhile the proximal portion engages and holds the obstruction.

In another aspect of the present invention, another obstruction removaldevice is provided which has at least one closed loop and preferably twoclosed loops. The closed loop provides an advantage when advancedthrough a catheter or sheath in that the closed loop produces opposingradial forces on the catheter or sheath through which the loop isadvanced. In this manner, the obstruction removal device can be advancedmore easily through the catheter or sheath to prevent binding or kinkingof the device during advancement. In a preferred embodiment, theobstruction removal device has two loops of varying diameter with thedistal loop having a larger diameter. Each of the loops lie in a planewith the planes of the two loops preferably being perpendicular to oneanother.

In another aspect of the invention, another obstruction removal deviceis provided which has wound sections formed by one or more filamentswhich are separated by sections substantially free of the filaments. Theintermittent wound sections provide discrete portions where theobstruction can be engaged. In an embodiment, the wound sections canslide on the core element to provide flexibility when advancing theobstruction removal device. The wound sections and sections free offilament are preferably about 1-5 mm long. The obstruction removaldevice preferably has at least three wound sections and more preferablyat least five wound sections.

In still another aspect of the invention, another obstruction removaldevice is provided which has alternating large and small diameterportions. In a preferred embodiment, the obstruction removal device hasat least four large diameter sections and three smaller diameterportions. The alternating large and small diameter portions may help toengage certain types of obstructions and can also help to prevent partsof the obstruction from breaking off and migrating downstream.

Any of the obstruction removal devices described herein may also be usedwith a source of power coupled to the obstruction removal device for useas described below. The source of power may simply produce a positive ornegative charge or may be an RF energy source. The source of power maybe used to help the obstruction removal device penetrate and engage theobstruction and may also be used to adhere the obstruction to theobstruction removal device as will be described. In a preferredembodiment, a negative charge is provided when advancing the obstructionremoval device into the obstruction and a positive charge, or RF energy,is supplied to adhere the device to the obstruction.

The devices of the present invention may be manufactured in any suitablemanner. In another aspect of the present invention, the obstructionremoval device has a core element surrounded by a sheath. A strand,preferably about four strands, are positioned between the core elementand the tube. The strand and the tube prevent any part of theobstruction removal device from breaking free should the core elementfail. The strand and tube will hold the obstruction removal devicetogether even if the core element breaks. The sheath is preferablyflexible so that the sheath can undergo much larger deflections than thecore element.

The obstruction removal devices of the present invention may also beadvanced through a guide catheter having a flow restricting elementwhich is preferably a balloon but may be any other suitable structure.The flow restricting element is expanded to reduce blood flow throughthe obstructed vessel to minimize the likelihood that the obstructionwill migrate downstream.

In another aspect of the invention, a system is provided which has anexpandable capture element and an obstruction engaging device whichtogether work to remove an obstruction from a blood vessel. The captureelement is advanced through the patient in a collapsed position and isexpanded when at the desired location. The obstruction engaging devicepreferably has one or more filaments which provide a relatively flexibleinteraction between the engaging device and the capture element. Thisprovides advantages over the use of a balloon catheter as described ingreater detail below. The obstruction engaging device preferably has 1-4filaments and more preferably 1-2 filaments. Of course, the obstructionengaging device may have more filaments without departing from variousaspects of the invention and, in fact, the device may form a filterwhich further helps to prevent portions of the obstruction from beingcarried downstream.

The capture element is preferably naturally biased toward the expandedposition although the capture element may also be manually actuated asdescribed below. The capture element has a support structure with aflexible cover attached thereto. The support structure preferably has aclosed loop which opens the distal end of the cover. The loop ispreferably integrally formed and has a number of integrally formedhinges which deflect when the loop is expanded and collapsed. The hingesare preferably V-shaped although other shapes may be used. A pluralityof struts extend proximally from the loop.

The capture element may also be expanded by the user so that the usermay select the appropriate time for expansion of the capture element. Inthis manner, the user may advance the capture element to a suitablelocation for expansion. The user may also collapse the capture elementbefore withdrawing the capture element into a catheter. The captureelement has an actuator for opening and closing the capture element. Theactuator may have a control arm and a stable arm although any suitableactuator may be used. The control arm is manipulated to expand andcontract a loop at the distal end of the capture element. Alternatively,the actuator may be a tube which cinches the loop closed. In a specificembodiment, the capture element may also evert when moving to theexpanded position.

The device of the present invention may be used in various differentlocations and for various different purposes. In one embodiment, thedevice may be used in connection with a guide catheter. When used withthe guide catheter, the device may be expanded to slow or even stopblood flow when performing other procedures downstream of the guidecatheter such as removing a clot or placing a stent.

Alternatively, the device may be passed through a conventional guidecatheter so that the device may be introduced further into thevasculature. In this system, the capture element passes through theguide catheter. The obstruction engaging device is then used to engagethe obstruction and move the obstruction into the capture element.

The present invention is also directed to methods and devices forremoving an obstruction where the obstruction engaging element has ashape which traps the obstruction. In one aspect, the element extendsproximally and then distally to ensnare the obstruction. The element mayhave such a shape naturally or may be moved into this shape bymanipulating the element. For example, the element may be rotated in oneor both directions to ensnare the obstruction. The element may have aportion which prolapses to capture the element as the element ismanipulated.

In still another aspect of the invention, the capture element invertswhen the obstruction is moved into the capture element. The obstructionis preferably engaged with an engaging element having a filament whichensnares the obstruction. The obstruction engaging element may beindependent from the capture element or may be connected to the engagingelement. The capture element inverts upon application of a compressiveforce to the inverting portion or upon any other suitable actuationforce. The capture element preferably inverts when the compressive forceis applied by either the obstruction or the engaging element.

The present invention is also directed to actuators for medical devices.In a first aspect, an actuator is provided which has an outer member anda plurality of fingers extending from the outer member. The fingers forman end that can be opened and closed by bending and straightening thefingers. The fingers may be bent by moving an inner member coupled tothe fingers or by tensioning or releasing tension on a filament. Themedical devices described above may be used for any suitable purposeincluding capture or containment of obstructions. For this purpose, thefingers or frame may be covered with the cover that forms an enclosureto hold the obstruction.

In another aspect, the medical device may have a frame that extends frominner and outer members. The frame forms an end that also opens andcloses. The frame has a first set of connectors coupled to the outermember and a second set of connectors coupled to the inner member. Theinner and outer members are movable relative to one another to open andclose the end. The frame may be an integral structure with the structurebeing deformed when the end opens and closes. In still another aspect,the frame may be made of a shape memory material which regains eitherthe closed or open position when heated or cooled. For example, theframe may be heated using electrical energy or other suitable source toactuate the frame.

These and other advantages of the invention will become apparent fromthe following description, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 shows a system for removing an obstruction.

FIG. 2 shows the obstruction removal device in a collapsed condition.

FIG. 3 shows the obstruction removal device with a distal portion of theobstruction removal device expanded.

FIG. 4 shows the obstruction removal device with a proximal portionexpanded to engage an obstruction.

FIG. 5 shows another obstruction removal device.

FIG. 6 shows yet another obstruction removal device.

FIG. 7 shows still another obstruction removal device.

FIG. 8 is an end view of the obstruction removal device of FIG. 7.

FIG. 9 is an exploded view showing a method of constructing anobstruction removal device.

FIG. 10 shows another system for removing an obstruction from a bloodvessel.

FIG. 11 shows a capture element in an expanded position with anobstruction engaging element engaging an obstruction FIG. 12 shows theobstruction moved into the capture element with the obstruction engagingelement.

FIG. 13 shows the capture element collapsed and contained within acatheter.

FIG. 14 shows an alternative structure for the capture element.

FIG. 15 shows another capture element.

FIG. 16 shows a distal end of the capture element of FIG. 15.

FIG. 17 shows the support structure for the capture element of FIGS. 15and 16.

FIG. 18 shows the capture element collapsed around the obstruction priorto withdrawal.

FIG. 19 shows the capture element contained within the catheter in aninverted position when collapsed.

FIG. 20 shows another support structure for the capture element with thesupport structure in an expanded position.

FIG. 21 shows the support structure of FIG. 20 in a collapsed position.

FIG. 22 shows still another support structure for the capture element.

FIG. 23 shows another capture element having a support structure whichbows outward to preferentially close the distal end.

FIG. 24 shows the capture element of FIG. 23 with an obstructioncontained within the capture element.

FIG. 25 shows another capture element.

FIG. 26 shows yet another capture element in an expanded position.

FIG. 27 shows the capture element of FIG. 26 in a collapsed position.

FIG. 28 shows another device for capturing an obstruction.

FIG. 29 shows the capture device of FIG. 28 advanced at least partiallyinto engagement with the obstruction.

FIG. 30 shows an obstruction engaging element advanced through thecapture element.

FIG. 31 shows the element engaging the obstruction.

FIG. 32 shows the obstruction partially contained within the captureelement.

FIG. 33 shows the obstruction completely contained within an invertedportion of the capture element.

FIG. 34 shows still another device for capturing an obstruction.

FIG. 35 shows the element engaging the obstruction.

FIG. 36 shows the inverting portion beginning to invert to capture theobstruction.

FIG. 37 shows the obstruction partially contained within the captureelement.

FIG. 38A shows the obstruction completely contained within the captureelement.

FIG. 38B shows the inverting portion contained within another cathetersuch as the guide catheter for removal from the patient.

FIG. 39 shows the distal end of the device of FIGS. 34-38 with theengaging element expanded.

FIG. 40 shows the distal end of the device of FIGS. 34-38 with theengaging element collapsed.

FIG. 41A shows an actuator for a medical device having which has adeformable frame being used as an obstruction capture device.

FIG. 41B shows the capture device with an obstruction contained therein.

FIG. 42A shows the actuator of FIG. 40 with the distal end closed.

FIG. 42B shows the capture device withdrawn into another catheter.

FIGS. 43A-D show the frame coupled to inner and outer members.

FIG. 44 shows another actuator having a frame made of a shape memorymaterial.

FIG. 45 shows the actuator of FIG. 43 with the distal end closed.

FIG. 46 shows still another actuator for a medical device.

FIG. 47 shows the actuator of FIG. 46 with a plurality of fingers in aclosed position.

FIG. 48 shows an alternate embodiment of the medical device of FIGS. 45and 46.

FIG. 49 shows the medical device of FIG. 48 with the fingers in a closedposition.

FIG. 50 shows the actuator of FIGS. 46-49 used to capture or remove anobstruction.

FIG. 51 shows the actuator of FIGS. 46-49 with the distal end closed tocapture the obstruction.

FIG. 52 shows another obstruction engaging element.

FIG. 53 shows the obstruction engaging element of FIG. 52 with theelement engaging an obstruction.

FIG. 54 shows the obstruction engaging element of FIGS. 52 and 53 withthe element having a prolapsed portion.

FIG. 55 shows another obstruction engaging element in an expandedposition.

FIG. 56 shows another device for removing an obstruction.

FIG. 57 shows the obstruction removing device of FIG. 56 expanded toengage the obstruction.

FIG. 58 shows another obstruction removing device in an expandedposition.

FIG. 59 shows still another obstruction removing device.

FIG. 60 shows yet another obstruction removing device.

FIG. 61 shows another obstruction removing device with a braided cover.

FIG. 62 shows an obstruction removing device with two side-by-sideelements.

FIG. 63 shows another embodiment with side-by-side elongate elements.

FIG. 64 shows an obstruction removing device having independentlymovable proximal and distal portions.

FIG. 65 shows still another obstruction removing device.

FIG. 66 is a cross-sectional view of FIG. 65 along line I-I.

FIG. 67 is a cross-sectional view of FIG. 65 along line II-II.

FIG. 68 shows another obstruction removing device.

FIG. 69 is an end view of FIG. 68 showing a larger opening between someof the wires.

FIG. 70 shows another obstruction removing device.

FIG. 71 is a side view of the device of FIG. 70.

FIG. 72 shows another obstruction removing device.

FIG. 73 is a side view of the device of FIG. 72.

FIG. 74 is an alternative side view of the device of FIG. 72.

FIG. 75 shows another obstruction removing device.

FIG. 76 shows another obstruction removing device.

FIG. 77 shows another obstruction removing device.

FIG. 78 is an end view of the obstruction removing device.

FIG. 79 shows another obstruction removing device.

FIG. 80 shows still another obstruction removing device having a loop.

FIG. 81 shows the device of FIG. 80 in a collapsed position.

FIG. 82 shows a cross-sectional view of FIG. 83 along line III-III.

FIG. 83 shows a side view of another obstruction removing element.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 1-4, a system 2 for removing an obstruction isshown. A guide catheter 4 is advanced to a location proximal to anobstruction. When accessing the cerebral vasculature, for example, theguide catheter 4 is often positioned in the carotid or vertebral artery.Of course, the guide catheter 4 may not be necessary or may bepositioned in any other suitable location depending upon the location ofthe obstruction. The guide catheter 4 preferably has a flow restrictingelement 6 which restricts or even stops blood flow through the vessel asdescribed below. The flow restricting element 6 is preferably a balloon5 coupled to a source of inflation fluid 7 which is used to inflate theballoon 5.

An obstruction removing device 8 is advanced through the guide catheter4 to the obstruction. A microcatheter 10 may also be positioned withinthe guide catheter 4 to deliver the obstruction removing device 8further into the vasculature. The obstruction removing device may beadvanced by itself through the microcatheter 10 or may be containedwithin a sheath 12 which is advanced through the microcatheter 10. Asource power 14 may also be coupled to the obstruction removal device 8for use in the manner explained below. The power source 14 may simplyproduce a positive or negative charge or may be an RF or other suitablepower source.

The obstruction removing device 8 has an engaging element 16 extendingfrom an insertion element 18. The engaging element 16 is movable from acollapsed position (FIG. 2) to an expanded position (FIGS. 3 and 4).When the engaging element 16 is contained within the sheath 12 ormicrocatheter 10, the engaging element 16 is in a relatively straightconfiguration. The engaging element 16 has a distal portion 20, whichforms a relatively closed structure, which can catch or trap theobstruction, or any part thereof, to prevent migration of theobstruction or part thereof. The engaging element 16 has a proximalportion 22 which is formed with smaller coils than the distal portion20. The proximal portion 22 engages the obstruction as described below.

The engaging element 16 preferably has a number of markers 23, 25, 27which provide an indication as to how much of the engaging element 16extends from the sheath 12 or microcatheter 10. For example, markers 23,25, 27 may indicate when the engaging element 16 is ½, ¾ or fullyexposed. In this manner, the user may quickly advance the engagingelement engaging element 16 through the sheath 12 or microcatheter 10without inadvertently exposing and advancing the engaging element 16 outof the sheath 12 or microcatheter. The markers 23, 25, 27 can also beused to provide a controlled diameter of the engaging element 16 sincethe diameter of the engaging element 16 is known for the variouspositions corresponding to the markers 23, 25, 27. The markers 23, 25,27 may also be used to size the vessel in which the engaging element 16is positioned by observing when the engaging element 16 engages thevessel walls and determining the size of the engaging element 16 usingthe markers 23, 25, 27.

The insertion element 18 is preferably made of a superelastic materialor stainless steel having a diameter of 0.004 to 0.038 inch andpreferably about 0.010 inch. Although the insertion element 18 ispreferably a solid, elongate element, the insertion element 18 may takeany other suitable structure such as a hollow tube. The engaging element16 is preferably made of a superelastic material, such as nitinol, andhas a diameter of 0.005-0.018 inch, more preferably 0.005-0.010 inch andmost preferably about 0.008 inch. The engaging element 16 has a rounded,atraumatic tip 24 to prevent damage to the vessel and facilitateadvancement through the vessel, microcatheter 10 and/or sheath 12. Aradiopaque wire 26, such as platinum ribbon 28 having a width of 0.004inch and a thickness of 0.002 inch, is preferably wrapped around theengaging element 16 to improve radiopacity.

The device 8 is preferably self-expanding but may also be expanded withan actuator 29. The actuator 29 is preferably a thin filament which istensioned to move the device 8 to the expanded position. An advantage ofthe invention is that the filament 29 extends through the same lumen asthe device 8 thereby minimizing the overall size of the device. It isunderstood that throughout discussion of the devices and methods hereinthat any of the devices may be expanded using the actuator 29 ratherthan being self-expanding without departing from the scope of variousaspects of the invention.

The device 8 may also include a cover 9 which extends between adjacentcoils. The cover 9 may be a number of individual strands 11 which extendbetween the coils or may be an elastic membrane which covers the coils.The strands 11 are preferably elastic to stretch when the device 8 isexpanded.

Use of the obstruction removing device 8 is now described. The guidecatheter 4 is introduced into the patient and delivered proximal to thetarget vessel such as to the carotid or vertebral artery. Themicrocatheter 10 is then advanced through the guide catheter 4 furtherinto the vasculature to a position proximal to, within or distal to theobstruction. The obstruction removal device 8 is then advanced throughthe microcatheter 10 either by itself or pre-loaded within the sheath12. The obstruction removal device 8 is then advanced to theobstruction. Before advancing the obstruction removal device 8 further,the flow restricting element 6 on the guide catheter 4 is expanded toreduce and even stop flow through the vessel. Stopping flow in thevessel may help prevent the obstruction, or any parts thereof, frommigrating downstream. Reducing flow through the vessel may also reducethe likelihood that the obstruction is disrupted by a combination offlow and the obstruction removal device 8.

The obstruction removal device 8 is then placed into the obstruction andpreferably through the obstruction. The engaging element 16 is thenadvanced out of the microcatheter 10 or sheath 12 to permit the distalportion 20 of the engaging element 16 to expand at a location beyond theobstruction. In this manner, the relatively closed distal portion 20prevents the obstruction, or any part thereof, from migratingdownstream. The proximal portion 22 is then advanced out of the sheath12 or microcatheter 10 so that the smaller coils of the proximal portion22 engage the obstruction as shown in FIG. 4.

Referring to FIG. 5, another obstruction removal device 8A is shownwherein the same or similar reference numbers refer to the same orsimilar structure. The obstruction removal device 8A has a first section30 with larger diameter coils than a second section 32. A third section34 also has larger coils than the second section 32 with the secondsection 32 positioned between the first and third sections 30, 34. Theobstruction removal device 8A may have a number of alternating small andlarge sections 30, 32, 34 which can enhance the ability of theobstruction removal device 8A to engage various obstructions. In thepreferred embodiment of FIG. 5, the obstruction removal device 8A hasfour large sections 32, 34 with relatively large coils and threesections 30 having smaller coils.

The obstruction removal device 8A may be used in any suitable manner toengage the obstruction. For example, the microcatheter 10 or sheath 12may be advanced through the obstruction and then retracted to expose theobstruction removal device 8A. The obstruction removal device 8A is thenretracted into the obstruction to engage the obstruction. Theobstruction removal device 8A may be rotated when moved into theobstruction to take advantage of the generally helical shape of theobstruction removal device. The obstruction removal device 8A may alsobe used to engage the obstruction by simply retracting the microcatheter10 or sheath 12 with the obstruction removal device 8A expanding withinthe obstruction. Finally, the engaging element 16A may be exposed andexpanded proximal to the obstruction and then advanced into theobstruction. When advancing the obstruction removal device 8A into theobstruction, the user may also twist the obstruction removal device 8Ato take advantage of the generally helical shape. The alternating largeand small sections 30, 32, 34 enhance the ability of the engagingelement 16A to engage varying shapes and sizes of obstructions.

Referring to FIG. 6, still another obstruction removal device 8B isshown wherein the same or similar reference numbers refer to the same orsimilar structure. The obstruction removal device 8B has the insertionelement 18 with an engaging element 16B extending therefrom. Theengaging element 16B forms a helical coil 38 with a generallyfrustoconical shape, however, the engaging element 16B may take anyother shape without departing from the scope of the invention includingany shape disclosed in this application or any patent incorporated byreference herein.

A filament 40, preferably a radiopaque filament, is wrapped around theengaging element 16B. The filament 40 is wrapped somewhat loosely aroundthe engaging element 16B so that the filament 40 provides additionalsurface area to engage the obstruction. The filament 40 forms a woundsection 42, and more preferably at least five wound sections 42, whichare separated by substantially exposed sections 44 of the engagingelement 16B. The wound and exposed sections 42, 44 may be 1-5 mm long.Stated another way, the wound and exposed sections 42, 44 are at least 1mm, more preferably at least 3 mm long, and no more than 8 mm long. Thewound sections 42 may be formed by a single filament 40 which extendscontinuously between the wound sections 42 or may be formed byindependent filaments 40 at each wound section 42 which are attached tothe engaging element 16B.

The wound sections 40 may be movable along the engaging element 16B toprovide flexibility when advancing the obstruction removal device 8Bthrough small and tortuous vessels. The movable wound sections 40 mayalso allow different parts of the obstruction removal device 8B to gripdifferent parts of the obstruction to hold the obstruction together orengage different parts of the obstruction. The obstruction removaldevice 8B is used in substantially the same manner as the otherobstruction removal devices described herein. The obstruction removaldevice 8B has a handle 41 with a lead screw 43 which engages threads 55.The handle 41 is rotated to advance and retract the engaging element16B.

Referring to FIG. 7, still another obstruction removal device 8C isshown wherein the same or similar reference numbers refer to the same orsimilar structure. The obstruction removal device 8C has an engagingelement 16C, which forms a first closed loop 50, and a second closedloop 52. The first loop 50 is preferably somewhat larger than the secondclosed loop 52 with the first loop 50 having a diameter of about 1.5-8.0mm and the second loop 52 having a diameter of about 1.5-6.0 mm. A tip54 extends from the first loop 50 for a distance of about 5 mm. Aradiopaque element 56, such as platinum ribbon, is preferably wrappedaround the loops 50, 52 to improve radiopacity and to enhance theability of the engaging element 16C to hold the obstruction. Theradiopaque element 56 also may provide advantages when engaging anobstruction in a manner similar to the obstruction removal devicesdescribed above with reference to FIG. 6.

An advantage of the obstruction removal device 8C is that the loops 50,52 exert substantially equal and opposing forces on the sheath 12 ormicrocatheter 10 through which the obstruction removal device 8C isadvanced. In this manner, kinking or binding of the obstruction removaldevice 8C during advancement can be minimized or reduced altogether.Referring to the end view of FIG. 8, the first and second loops 50, 52preferably lie in first and second planes 58, 60, respectively, whichare preferably perpendicular to one another.

Another method of aiding mechanical capture of an obstruction is to coatthe device and elements of the present invention with a material 61which helps to adhere the obstruction, and in particular thrombus, tothe device or element. The material 61 is preferably fibrin but may beany other suitable material. Use of the material 61 may be incorporatedinto any of the devices described herein or other suitable device suchas the devices shown in FIGS. 2-8, 22 or 30.

Referring to FIG. 9, an exploded view of a construction of theobstruction removal device 8, 8A, 8B, 8C is shown. A tube 62, which ispreferably a thermoplastic polymer such as polyester or urethane ispositioned over a core element 64. As mentioned above, the core element64 is preferably a superelastic or stainless steel element at either theinsertion element 18 or the engaging element 16 (FIGS. 2-7). Areinforcing strand 66 is trapped between the tube 62 and the coreelement 64 to reinforce the obstruction removal device. The strand 66 ispreferably small and has a diameter or thickness of less than 0.005inch, more preferably less than 0.0001 inch, so that the overall size ofthe obstruction removal device is not increased significantly with useof the strand 66. The strand 66 may be made of any suitable materialincluding VECTRAN made by Celanese Acetate LLP or DACRON or KEVLAR whichare both manufactured by Dupont. VECTRAN is a thermoplasticmultifilament yarn spun from a liquid crystal polymer.

The strand 66 provides a degree of safety in that the strand 66 and tube62 together prevent any part of the obstruction removal device frombreaking free from the rest of the device. The tube 62 will resistbreaking since it is more flexible than the core element 64 and canundergo larger deflections and displacements without breaking. In apreferred embodiment, 2-8 strands 66, preferably about 4 strands 66, areused. The overall size of the device is also relatively small with theouter diameter of the resulting structure being no more than 0.020 inchand more preferably no more than 0.012 inch.

The power source 14 may be also be used with any of the obstructionremoval devices in the following manner, however, the methods anddevices of the present invention may, of course, be practiced withoutthe power source 14. As mentioned above, the power source 14 may simplyproduce a charge at the engaging element 16 or may be a source of RFenergy. In one particular method of the present invention, the powersource 14 produces a negative charge while advancing the engagingelement 16 through the obstruction. The negative charge may aid inpassing the engaging element 16 through the obstruction and may help todissolve part of the obstruction. The power supply is then changed toproduce a positive charge to adhere the obstruction to the engagingelement 16. Alternatively, the power source 14 may be an RF energysource, which delivers RF to the engaging element 16 which also adheresthe obstruction to the engaging element 16 and may help provide acontrolled penetration into the obstruction. The obstruction is thenremoved by moving the obstruction into the guide catheter 4, which isthen withdrawn to remove the obstruction. Use of the power source 14 isparticularly useful when the obstruction is a biologic structure such asa clot.

Referring to FIGS. 10-14, another system 100 for removing an obstructionis shown. The system 100 is particularly useful for removing clots andthrombus from blood vessels but may also be used to remove otherobstructions such as embolic coils and the like. The system 100 includesan expandable capture element 102 and an obstruction engaging device 106which work together to capture the obstruction. The obstruction engagingdevice 106 engages the obstruction and moves the obstruction into thecapture element 102 as described below. After the obstruction has beencaptured, the capture element 102 may then be used in various ways forultimate removal of the obstruction. The capture element 102 may beadvanced through the guide catheter 4 or through another catheter 107which is advanced through the guide catheter 4. As will be explainedbelow, the capture element 102 is preferably advanced over theobstruction engaging device 106.

The obstruction engaging device 106 may be any of the engaging orremoval devices described herein or any other suitable device. Variousaspects of the invention preferably include one or more features of theobstruction removing devices described herein and all aspects, features,dimensions, and characteristics of the obstruction removing and engagingdevices described herein are incorporated here. It is understood thatthe term obstruction removal device and obstruction engaging device areinterchangeable. The obstruction engaging device 106 may be containedwithin the sheath 12 or may be advanced by itself through the guidecatheter 4 and/or catheter 107.

The engaging device 106 may have one or more filaments 108, preferably1-4 and more preferably 1-2 filaments, which engage the obstruction. Thefilament 108 forms a relatively small, flexible interaction between theengaging device 106, capture element 102 and obstruction which providesadvantages over the prior art method of using a balloon catheter. Thefilament 108 may deflect and displace to accommodate the geometry andorientation of the obstruction when the obstruction enters the captureelement 102. The interaction between the balloon catheter and theexpandable catheter of the prior art tends to shear off portions of theobstruction due to the relatively rigid interaction between the ballooncatheter and expanded catheter. The filament 108 also has a relativelysmall size which further enhances the flexibility of the obstructionengaging device 108. The filament 108 may also form one or more loops110 which further serve to create a soft, flexible interaction betweenthe obstruction engaging device 106 and capture element 102. Thefilaments 108 may also form a filter which further prevents theobstruction or portions thereof from travelling downstream.

The capture element 102 preferably has a support structure 112 with aflexible cover 114 attached thereto. The support structure 112 ispreferably self-expanding although the support structure 112 may also beselectively expanded by the user as explained below. The supportstructure 112 preferably has a loop 116 having integrally formed hinges117. The hinges 117 are preferably formed by V-shaped interconnectingelements 120 although other shapes, such as U-shaped, may be used. Theloop 116 is preferably formed as an integral structure with the loop 116being formed from a tube of material which is cut, etched, treated orotherwise formed into the loop 116 with hinges 117. The loop ispreferably made of a superelastic material although any suitablematerial may be used.

Struts 122 extend proximally from the loop 116. The struts 122 do notintersect and generally form a cone 124 when expanded. The struts 122are coupled to a lumen 121 which receives the engaging device 106 sothat the capture element 102 can be advanced over the engaging device106 as described below. Referring also to FIG. 14, the struts 122 mayalso be coupled together at a hub 126 at the proximal end. The hub 126has a lumen 127 which receives the engaging device 106. A shaft 128extends from the hub 126 and is used to manipulate the capture element102. The struts 122 are preferably made of a superelastic material orstainless steel and are attached to the closed loop 116 by soldering,welding, glue or any other suitable attachment method. The struts 122may also be integrally formed with the loop 116. Of course, thesupporting structure 112 may be made of any other suitable material andmay be formed in any other suitable manner. The struts 122 may also bebowed outward so that the distal end of the device is preferentiallyclosed before the entire device has been withdrawn as shown in FIGS. 23and 24.

The cover 114 is preferably attached to the support structure 112 withglue, thread, suture or any other suitable method. The cover 114preferably lies over the support structure 112 but may also be containedwithin the support structure 112. The cover 114 is relatively long toensure that the entire obstruction is captured. The cover 114 ispreferably at least three times, more preferably at least five times,and most preferably at least seven times larger than the maximumexpanded diameter of the support structure 112 or cover 114. Of course,the capture element 102 may have any other suitable dimensions dependingupon the particular application. The cover 114 is preferably made ofePTFE but may be made of any other suitable material. The cover 114 mayalso be a mesh-like structure, or any other suitable expandablestructure which can contain the obstruction and parts thereof, withoutdeparting from the scope of the invention.

Various methods of the present invention are now described. The methodsare described in connection with system 100 of FIGS. 10-14 but may bepracticed with other suitable devices and systems. The present inventionis well-suited for use in the cerebral vasculature and a cerebralapplication is described, however, the invention may be practiced inother vascular locations as well.

The guide catheter 4 is advanced to a suitable location. The obstructionengaging device 106 is then advanced through the guide catheter 4.Referring to FIGS. 11 and 12, the obstruction engaging device 106 isthen used to engage the obstruction in any manner described herein. Forexample, the sheath 10 (see FIG. 10) may be advanced through theobstruction and then retracted so that a proximal portion 111 of thedevice 106 is contained within the obstruction. The device 106 is thenmoved proximally, and is preferably twisted, so that the loops 110engage the obstruction. In the specific embodiment of FIGS. 11-14, thedevice 106 ensnares the obstruction with the loops 110 when twisted andmoved proximally.

The capture element 102 is then advanced over the engaging device 106.The capture element 102 may be advanced through the guide catheter 4 ormay be advanced through the catheter 107 which is advanced through theguide catheter 4 further into the cerebral vasculature. The captureelement 102 is then moved out the catheter 107 or guide catheter 4 sothat the capture element 102 expands. The obstruction is then moved intothe capture element 102 with the device 106 as shown in FIG. 13. Whenthe obstruction is contained within the capture element 102, the captureelement 102 is then withdrawn into the catheter 107 or guide catheter 4as shown in FIG. 14. The catheter 107 and/or guide catheter 4 are thenwithdrawn from the patient thereby withdrawing the obstruction.

It may be desirable to reduce or even stop blood flow through the bloodvessel during the procedure to reduce flow forces on the obstructionwhen manipulating the obstruction. Reducing flow in the vessel may alsoprevent some parts of the obstruction from breaking off and flowingdownstream before entering the capture element 102. Referring again toFIGS. 10 and 22, blood flow may be reduced by inflating a balloon 131 onthe guide catheter 4 or the catheter 107. The balloon 131 is inflatedusing a suitable source of inflation fluid 133. Alternatively, thecapture element 102 itself may also be used to reduce blood flow throughthe vessel. The capture element 102 naturally impedes blood flow sinceit expands within the blood vessel. The capture element 102 may also bedesigned to only partially occlude the vessel so that some blood flow isprovided to the area downstream from the capture element 102. The device102 may be modified to include a second loop 130 extending between thestruts 122 to enhance the ability of the device 102 to occlude thevessel. The loop 130 preferably has the features of the loop 116.Although it is preferred to reduce or even stop flow in the vessel, theinvention may also be practiced without reducing blood flow.

The devices and methods of the present invention may also be practicedwith a source of vacuum 135 providing suction during capture of theobstruction. The source of vacuum 135 may be activated during engagementof the obstruction with the device 106, movement of the obstruction intothe capture element 102, and/or withdrawal of the capture element 102into the catheter 107 or guide catheter 4. The source of vacuum 135 iscoupled to the guide catheter, 4, catheter 107 and lumen 121 for thesepurposes.

Referring to FIGS. 10 and 15-17, another capture element 132 forremoving an obstruction is shown wherein the same or similar referencenumbers refer to the same or similar structure. The capture element 132is selectively expandable by the user which provides various advantagesdescribed below. The cover 114 is attached to a catheter 134 near or atthe distal end 135. The catheter 134 may be the guide catheter 4 or thecatheter 107 in the system 100 described above. An expandable andcollapsible loop 136 is attached to the distal end of the cover 114 toexpand and collapse the distal end of the cover 114. The loop 136 isexpanded and collapsed by manipulating an actuator 138 which includes acontrol arm 140 and a stable arm 142. The control arm 140 extends andslides through an eyelet 144 when expanding and collapsing the loop 136.The stable arm 142 extends from the loop 136 at or near the eyelet 144to stabilize the loop 136 when moving the control arm 140. The cover 114is attached to the loop 136 using any suitable method. For example, thedistal end may be inverted to create a fold 141 which surrounds the loop136.

Another advantage of the capture element 132 is that the capture element132 may be selectively expanded and contracted by the user. The captureelement 132 may be fully or partially collapsed to trap the obstructionprior to withdrawal of the capture element 132 into the catheter 107 orguide catheter 4 as shown in FIG. 18. In fact, the capture element 132may be withdrawn by itself by simply closing the distal end andwithdrawing the capture element 132. In this manner, the capture element132 protects the obstruction during withdrawal and prevents theobstruction from escaping. This provides obvious advantages over thesystem of Guenther described above.

Referring to FIGS. 10 and 19, still another capture element 150 is shownin which the same or similar reference numbers refer to the same orsimilar structure. The capture element 150 has the cover 114 and theactuator 138 which includes the stable arm 142, control arm 140, andloop 136 although other actuating structures may be used. The captureelement 150 is contained within the catheter 107 or the guide catheter 4during introduction and is then everted out of the catheter 107 orcatheter 4 when deployed. The capture element 150 may be used insubstantially the same manner as the other capture elements describedherein and in particular the capture element 132 of FIGS. 15-17. Thecapture element 150 may also be used to further collapse the cover 114since the actuator 138 may be used to close the distal end with thecover 114 deployed. After the obstruction is contained within thecapture element 150, the capture element 150 is withdrawn into thecatheter 107 or catheter 4. Although it is preferred to withdraw thecapture element 150 into the catheter 4 or catheter 107, the captureelement 150 may be collapsed and then inverted back into the catheter 4,107 thereby trapping the obstruction in the catheter 4, 107 itself.

Referring to FIGS. 20 and 21, the distal end of yet another captureelement 152 is shown in which the same or similar reference numbersrefer to the same or similar structure. The capture element 152 has aself-expanding support structure 154 with an expandable loop 156 at thedistal end. The loop 156 has a tube 158 which receives a wire 160 atboth ends. The slidable connection between the tube 158 and wire 160permits the loop 156 to contract and expand between the positions ofFIGS. 20 and 21. Struts 162 extend from the loop which engage thecatheter to collapse the loop 156. The cover 114 is attached to the loop156 by any suitable method. The capture element 152 is used in anymanner described herein. The capture element 152 is used in any mannerdescribed herein and those methods are incorporated here.

Referring to FIG. 25, still another device 170 is shown wherein the sameor similar reference numbers refer to the same or similar structure. Thedevice 170 is similar to the device of FIG. 15 in that the device 170may be selectively expanded and collapsed by the user. The device 170has a collar 172, which may also be a continuous sheath or tube, whichslides over the catheter 107 or sheath 12. The engaging device 106passes through the catheter 107 or sheath 12 (FIG. 10) and is used inthe manner described herein. A 174 wire, or other elongate member, iscoupled to the collar 172 for advancing and manipulating the collar 172.

The cover 114 is coupled to a loop 176 which is selectively expanded bythe user as now explained. The loop 176 is manipulated with the actuator138 which may be any suitable mechanism. The actuator 138 has a wire 139passing through an actuator tube 178 and may also include the stable arm142. The wire 139 is coupled to the loop so that movement of the wire139 opens and closes the loop 176. The actuator tube 178 may be simplyadvanced to cinch the loop 176 closed. The loop 176 is preferablynaturally biased toward the open position and is held closed by the tube178.

The device 170 is used in substantially the same manner as the otherdevices described herein and discussion of those methods arespecifically incorporated here. The device 170 may be advanced by itselfthrough the vasculature with the tube 178 holding the loop 176 in theclosed position. The cover 114 is advanced by manipulating the tube 178,wire 139 and wire 174. The cover 114 is advanced over the catheter 107or sheath 12 and the tube 178 is retracted to permit the loop 176 toexpand. The obstruction is then introduced into the cover 114 and thecover 114 is then closed by advancing the tube 178 to cinch the loop 176closed. The actuator 138 may also be manipulated to open or close theloop 176 together with the tube 178 or independently of the tube 178.

Referring to FIGS. 26 and 27, still another device 180 is shown whereinthe same or similar reference numbers refer to the same or similarstructure. The device 180 has the cover 114 and a loop 182 coupled tothe distal end of the cover 114. Stabilizing struts 184 extend from anend 186 of a tubular body 188 to the loop 182. Actuating arms 190 extendthrough the body 188 and are also attached to the loop 182. The arms 190are manipulated to move the loop 182 between the collapsed and expandedpositions of FIGS. 26 and 27. The engaging device 106 passes through thebody 188 and may be delivered through the catheter 107 or sheath 12. Thedevice 180 is used in substantially the same manner as the device ofFIG. 15 and discussion of those methods are incorporated here.

Referring to FIGS. 28-33, another capture element 200 is shown forcapturing an obstruction. The capture element 200 has an invertingportion 202 that inverts to entrap the obstruction. The capture element200 is then withdrawn into the guide catheter 4 (FIG. 1) for removal ofthe obstruction from the patient.

Referring to FIG. 31, the engaging element 204 is shown engaging theobstruction. The element 204 may be any suitable element such as theobstruction engaging elements and removal devices described herein. Theelement 204 passes through a lumen 205 in the capture element 200. Theengaging element 204 may be advanced through the capture element 200 byitself or may be contained within the microcatheter 10 or sheath 12(FIGS. 1 and 2) which is advanced through the capture element 200.

The capture element 200 has a distal portion 207 which is flexible andwhich may be partially contained, engaged or otherwise in contact withthe obstruction as shown in FIG. 29. The distal portion 207 may alsoinvert but preferably does not invert. The distal portion 207 necks-downat a distal end 209 to a size smaller than the guidewire GW so that thecapture element 200 is advanced together with the guidewire. Of course,the capture element 200 may also be advanced by itself afterintroduction of the guidewire and may be contained within or advancedover another catheter without departing from the invention.

The element 204 engages the obstruction in any suitable manner. Theinverting portion 202 is then inverted by applying a compressive forceto the inverting portion 202. The compressive force is applied by movingthe capture element 200 relative to the engaging element 204 whichcauses the element 200 and/or obstruction to compress the invertingportion. Continued relative movement moves the obstruction into theinverted capture element 200 as shown in FIGS. 32 and 33 to capture theobstruction. The capture element 200 is then moved into the guidecatheter 4 (FIG. 1) for removal from the patient. The capture element200 may be made of any suitable materials. For example, the distalportion 207 may be made of any suitable polymeric material such as thosedescribed herein and the inverting portion 202 may be made of a braidedor woven material or fabric made of fibers or filaments of nitinol,stainless steel, polymer or other material.

Referring to FIGS. 34-40, another capture element 210 for removing anobstruction is shown wherein the same or similar reference numbers referto the same or similar structure. The capture element 210 also has aninverting portion 212 connected to an end 213 of a delivery element 214which may be a hollow tube, sheath or catheter. The distal end of thecapture element 210 has a collar 214 attached to a proximal end 216 ofan engaging element 218. A distal end 220 of the obstruction engagingelement 218 is attached to an inner element 222 such as a wire, mandrelor guidewire. The collar 214 slides over the inner element 222 so thatwhen the inner element 222 and delivery element 214 are movable relativeto one another. Relative movement between the inner element 222 anddelivery element 214 moves the obstruction engaging element 218 betweenthe expanded and collapsed positions (FIGS. 39 and 40) and also cancollapse the capture element 210. The engaging element 218 is similar tothe other elements and devices described herein in that the element hasa filament 224 which is tensioned to collapse the filament 224. Thefilament 224 forms coils 226 around the inner element 222.

The capture element 210 and obstruction engaging element 218 areadvanced through the patient in either the sheath 12 or microcatheter 10(FIGS. 1 and 2). The capture element 210 and obstruction engagingelement 218 are then positioned distal to the obstruction and theobstruction is engaged with the element 218. The capture element 210 andengaging element 218 are then moved relative to one another to invertthe capture element 210 as described above.

Referring to FIGS. 41-43, another aspect of the present invention isshown which provides an actuator 228 for a medical device 230. Theactuator 228 may be used for actuating any medical device and a specificexample is a capture element or an obstruction removal device. Themedical device 230 has a frame 232, an outer member 234 and an innermember 236 positioned within the outer member 234. The frame 232 extendsdistally from the inner and outer members 236, 234.

The frame 232 has a distal end 238 which moves between the open (FIGS.41A and B) and closed (FIGS. 42A and B) positions. The frame 232 has afirst set of connectors 240 coupled to the outer member 234 and a secondset of connectors 242 coupled to the inner member 236. The inner andouter members 236, 234 are moved relative to one another so that theframe 232 is deformed to open and close the distal end between thepositions of FIGS. 41A and B and 42A and B. The inner and outer members236, 234 are preferably tubes but may be any other suitable structurethat permits longitudinal movement of the connectors 240, 242 in themanner described. The connectors 240, 242 extend longitudinally to aring 241 formed of V-shaped elements 243. The connectors 240 attached tothe inner member 236 are coupled to intersections 245 of the ring 241and the other connectors 240 are attached to the other intersections 247of the ring. Stated another way, the connectors 240, 242 are attached atspaced apart positions on the ring with one connector 240 between eachpair of connectors 242. The frame 232 is preferably integrally formed ina manner similar to a stent. For example, the frame 232 may be formed byremoving material from a tube to provide the frame structure.

A cover 233 may be provided over or under the frame 232 so that theframe 232 acts as an actuator 244 to open and close the cover 233. Thecover 233 may be used in the same manner as any of the capture elementsdescribed herein. To this end, any of the obstruction engaging elementsdescribed herein may be used with the device to trap and removeobstructions.

Referring to FIGS. 44 and 45, still another medical device 250 is shownwhich is similar to the medical device 230 of FIGS. 41-43. The medicaldevice also has a frame 252 having a distal end 254 which opens andcloses. The frame 252 is made of a shape memory material which eitherrecovers the open or closed position when heated. The shape memorymaterial may be heated in any suitable manner including use of a heatedfluid or by applying electrical energy which heats the frame 252 tocause the frame to assume the recovered shape. FIG. 45 shows the frame252 assuming the collapsed shape upon application of electrical energyfrom an energy source 253. The cover 233 may also be provided so thatthe frame acts as an actuator for still another capture device. FIGS. 45show the medical device 250 being used to capture an obstruction. Thedevice 250 is then withdrawn into the guide catheter or other suitablecatheter for removal of the obstruction.

Referring to FIGS. 46-51, still another actuator for a medical device256 is shown. The characteristics of the medical device 256 may be usedto form any device. The medical device 256 has a plurality oflongitudinally extending fingers 258. The fingers 258 are normally in arelatively straight configuration. The fingers 258 are bent inward sothat a distal end 260 closes (FIG. 47). The fingers 258 may be attachedto the cover 233 to open and close the cover 233 with the fingers 258.The fingers 258 are preferably bent by tensioning flexible, elongatemembers 262. The elongate members 262 may be attached to an inner member264 (FIGS. 46 and 47) or an outer member 265 (FIGS. 48 and 49). Any ofthe obstruction engaging elements may be used with the medical device toremove an obstruction in any manner described herein. For example, FIGS.50 and 51 show the medical device 256 being used to capture or remove anobstruction. The device 256 may be used to capture or engage theobstruction by itself or in cooperation with any a suitable engagingelement 257.

Referring to FIGS. 52-55, another obstruction engaging element 270 isshown. The obstruction engaging element 270 includes a filament 272which forms windings or coils 274. The windings 274 may take anysuitable shape such as helical. The obstruction engaging element 270 isadvanced to an obstruction in any manner described herein. For example,the obstruction engaging element 270 may be contained within the sheath12 or catheter 10 (FIGS. 1 and 2) and advanced through the obstruction.The obstruction engaging element 270 is then advanced out of the sheath12 or catheter 10 (FIGS. 1 and 2) to permit the obstruction engagingelement 270 to expand.

When the element initially expands, the coils 274 do not overlap whenviewed along a longitudinal axis L. The element 270 is then engaged bymanipulating the element 270. After the obstruction has been engaged,the element 270 is rotated which tends to open the coils 274. Thiscauses one or more proximal coils 274 to prolapse over other coils toensnare the obstruction. Stated another way, the element 270 initiallyextends distally in a relatively continuous manner. After rotating theelement 270, the element extends distally, then proximally, thendistally again. Stated yet another way, the coils are manipulated sothat they appear to overlap when viewed along the longitudinal axis L.The prolapsed or overlapping coils 274 may provide an even more secureengagement to the obstruction. The element 274 may also be formed tohave the overlapping or prolapsed sections when in the natural, unbiasedand expanded position as shown in FIG. 54.

Referring now to FIGS. 56 and 57, still another device 280 for removingan obstruction is shown. The device 280 may be used in any suitablemanner described herein. For example, the device 280 may be advanced byitself or advanced while contained in a sheath or catheter. The sheathor catheter 281 holds the device 280 in a substantially straightconfiguration. The device 280 has an elongate element 282, such as awire 284, which expands to the expanded shape of FIG. 57 similar toother embodiments described herein. The elongate element 282 has adistal end 286 coupled to an insertion element 288. A proximal end 290of the elongate element 282 is coupled to a collar 292, which slides onthe insertion element 288. Sliding of the collar 292 permits theelongate element 282 to move between the collapsed and expandedpositions of FIGS. 56 and 57. The insertion element 288 also has a stop294, which prevents movement of the collar 292 beyond the position ofFIG. 57.

Still another device 300 is shown in FIG. 58. The device 300 is similarto many of the other devices described herein and may be used in anymanner described herein. The device 300 is formed by an elongate element302, such as a wire 304, which forms a number of coils 306. The device300 has larger coils 308 at a distal portion 310 and smaller coils 312along an intermediate portion 314. The smaller coils 312 are preferablystiffer than the larger, distal coils 308. In this manner, excessiveelongate of the device can be reduced since the stiffer coils 312 helpto resist elongation of the element 302 when the element is pulled. Thedevice 300 is also particularly useful when using the following routineto remove an obstruction. The device 300 is positioned in a catheter orsheath which is advanced through the obstruction. The distal coils 308are expanded distal to the occlusion but may be expanded within theobstruction as well. The device 300, and catheter if necessary, are thenmanipulated to expose the intermediate portion 314 within theobstruction. The intermediate portion 314 expands within the obstructionand engages the obstruction. The stiffer, intermediate portion 314resists elongation when withdrawing or moving the obstruction so thatthe device 300 maintains good contact with the obstruction. The larger,distal coils 308 help to trap the obstruction and prevent parts of theobstruction from trailing or escaping removal. The device 300 also has aproximal portion 316, which may be expanded proximal to the occlusion sothat the occlusion is substantially trapped between the proximal anddistal portions 316, 310.

Referring to FIG. 59, another device 319 is shown which is similar tothe device of FIG. 58. The device 300 has distal, intermediate andproximal portions 318, 320, 322. The proximal portion 322 differs fromthe proximal portion 316 of FIG. 58 in that the proximal portion 322winds distally, then proximally, then distally again. The back-and-forthwinding of the proximal portion 322 increases the stiffness of theproximal portion 322 which may help resist elongation of the deviceduring withdrawal of the obstruction. If the device begins elongatingduring manipulation of the obstruction, the obstruction will engage theproximal portion which then helps to resist further elongation of thedevice. The device 319 may be used in the manner described above inconnection with FIG. 58 in that the intermediate portion may be deployedwithin the obstruction.

Referring to FIGS. 60 and 61, an obstruction removing element 327, whichmay be any of the devices described herein or another suitable device,may also be covered with a flexible cover 328. In the preferredembodiment, the element 327 is an elongate element 327 such as a wire.The flexible cover 328 is preferably not rigidly adhered or attached tothe element 327 so that the cover 328 has some freedom to move on theelement 327. The cover 328 may be a flexible tube 330, such as an ePTFEtube or ribbon, which extends over the element 327. The tube 330 is veryflexible and provides no structural properties to the element 327 andessentially follows the shape of the element 327. The tube 330 maysimply extend through the element 327 or the element 327 may pass in andout of the tube as shown in FIG. 60. The cover may also be a braidedstructure 332 positioned over the element 327 as shown in FIG. 61. Thecover 328 adds no significant stiffness or structural properties to theelement 327 and can also be made very small and, therefore, does notsubstantially impact the size or advanceability of the device 327. Whendeployed, however, the cover 328 may fold, crease or bunch up whichtends to increases the surface area of the element 327 for engaging theobstruction when expanded. The braided cover 332 can also help to filterthe fluid flow to trap loose parts of the obstruction.

Referring to FIG. 62, another device 334 for removing an obstruction isshown. The device 334 is similar to other devices described herein andall methods described herein may be used with the device 334. The device334 has a first elongate element 336 which may form coils 338 or othersuitable structure when expanded. A second elongate element 34 0 extendsnext to the first elongate element 336 and forms substantially the sameexpanded shape as the first elongate element 336. The second elongateelement 340 may be a filament 342, such as suture 346, which does notadd significant structural properties to the device 334 similar to thecover 328 described in connection with FIGS. 60 and 61. The suture 346may be attached to the first elongate element 336 at various points sothat the suture 346 essentially follows the shape of the first elongateelement 336. Alternatively, the second elongate element 340 may be awire or ribbon which provides some structural properties. Referring toFIG. 63, for example, the first elongate element 336 is a round coilwhile the second elongate element 342 is a ribbon coil. The secondelongate element 342 is wrapped around the first elongate element 336 atthe distal end and extends parallel to the first elongate element 336through an intermediate 344 or expandable section. The second elongateelement 342 is again wrapped around the first elongate element 336 at aproximal portion 346. The second elongate element 342 may also formreinforcing 348 for the insertion element 350 as shown in FIG. 63 byencasing the second elongate element 342 in suitable polymer 352 to forma shaft as is known in the art.

Referring to FIG. 64, still another device 356 is shown for removing anobstruction. The device 356 has a proximal obstruction removing element358 and a distal obstruction removing element 360. The elements 358, 360are preferably independent so that they may be manipulatedindependently. Each of the obstruction removing elements 358, 360 may beany of those described herein or any other suitable structure. In oneaspect of the invention, the distal obstruction removing element 360 maybe deployed within or distal to the obstruction. The other element 358is deployed on the proximal side of the obstruction, or within aproximal portion of the obstruction, to provide further control andentrapment of the obstruction. The proximal obstruction removing elementmay also be used to resist and prevent excessive elongation of thedistal obstruction removing element 360 when the distal removing element360 is pulled to move the obstruction. The elements 358 may extendthrough the same multi-lumen catheter or may be provided in separatecatheters without departing from the scope of the invention.

Referring to FIGS. 65-67, still another device 362 for removing anobstruction is shown. The device 362 has an insertion element 364 andstruts 366, preferably 2-4, extending from a distal end of the insertionelement 364. Arms 368 extend from the struts 366 to form a cage-likestructure 370. The device 362 preferably has at least two arms 368,preferably 2-4 arms, extending from the end of each strut 366. Forexample, FIG. 64 shows two struts 366 with three arms 368 extending fromeach strut 366. In another example, three struts 366 may be used withtwo arms 368 extending from each strut 366. The struts 366 arerelatively short when viewed along the longitudinal axis and may be lessthan ½, and more preferably less than ⅓, the length of the arms 368. Thedistal end of the arms 368 are coupled together to form a tip 372 of thecage-like structure 370.

Referring now to FIGS. 68 and 69, still another device 374 is shown forremoving obstructions. The device 374 has a cage-like structure 376formed by a number of elongate elements 378 such as wires 380. The wires380 are coupled together at proximal and distal ends 382, 384 to formthe cage-like structure. The wires 380 may be substantially independentand are preferably not braided or woven. The elongate elements 378 maybe wound helically, although other shapes and patterns may be used, withthe elements 378 all wound in the same direction. Although cross-membersor cross-elements may be provided, it is preferably to omit suchcross-members and cross-elements. An advantage of providing therelatively independent elements 378 is that the entire structure may becollapsed to a smaller size than typical woven or braided elements.Referring to FIG. 69, an end-view of the device 374 shows that a largerspacing 386 between two of the wires 380 to permit the obstruction topass into the opening. The other end, such as the distal end, preferablyhas a more symmetrical pattern to minimize the size of the openings andprevent the obstruction from escaping through the distal end. Theproximal portion may also form larger coils than the distal section sothat the obstruction may pass through openings in the proximal portionbut is prevented from escaping through the distal end.

Referring now to FIGS. 70-79, various other devices for removing anobstruction are shown. The devices are held in a substantially straight,collapsed position when contained in a sheath or catheter as describedherein. Referring to FIG. 70, an elongate element 392, such as a wire394, forms a number of discrete structures 396 when permitted to expand.The discrete structures 396 may take any shape such as a circularstructure (FIG. 72), or a flower-petal like structure (FIGS. 70 and75-78). In one aspect, the structures 396 may be substantially parallelto one another (FIG. 71). In another aspect, the discrete structuresextend from a side of an otherwise straight portion of the wire (FIG.73) or may be centered with respect one another (FIG. 74). The discretestructure 396 may also have different sizes (FIGS. 73 and 74). Thediscrete structures 396 may also be oriented to create an interferingpattern as shown in the end view of FIG. 78. The discrete structures 396may also be formed somewhat continuously as shown in FIG. 79.

Referring to FIGS. 80 and 81, still another obstruction removing device400 is shown. The obstruction removing device 400 has a loop 402 and abasket 404 attached to the loop 402. The basket 404 may be formed in anysuitable manner such as with a number of filaments 406 or wires. Ofcourse, an integral structure, bag or any other structure may be used toform the basket 404. The basket 404 primarily forms a chamber 408 toreceive the obstruction. The loop 402 is deflected into the collapsedposition of FIG. 81 and expands to the position of FIG. 80. The loop 402is an elongate oval in the collapsed position with the loop 402generally lying in a plane P1 which is about 0-25 degrees relative to alongitudinal axis LA of the device. When the loop 402 expands, the loop402 becomes less elongate and may form a circle. The loop 402 lies in aplane P2 which is preferably about 45-135 degrees, more preferably70-110 degrees, relative to the longitudinal axis when LA in theexpanded position.

The loop 402 may have a varying size or may have a constant perimetersize. In the embodiment of FIG. 80, the loop 402 substantially maintainsthe same perimeter size when moving between the expanded and collapsedpositions with the loop 402 being simply deformed when collapsed. Theloop may be formed by a single filament or wire 406 with the wire 406having first and second ends 410, 412 coupled to an insertion element414. The first and second ends 410, 412 are attached to the insertionelement 414 with a platinum coil 416 wrapped around the first andseconds ends 410, 412 and the insertion element 414. Of course, anyother method may be used to attach the loop including simply solderingor gluing the loop to the insertion element or using two or more wiresor elements attached to one another. Thus, it can be appreciated thatthe deformable loop of the present invention may be provided in a numberof different ways without departing from the scope of the invention. Thewires 406 may also be wrapped with a radiopaque element such as platinumwire.

In use, the device of FIGS. 80 and 81 is deployed distal to theobstruction so that the loop 402 expands distal to the obstruction. Theinsertion element 414 is then manipulated to move the obstruction intothe chamber 408 of the basket 404. The loop 402 may be sized to expandto a size and shape similar to the vessel in which it is being deployed.The loop 402 may then be partially or totally collapsed to preventescape of the obstruction or parts thereof. The device is then removedin any suitable manner such as through a guide catheter.

Referring to FIGS. 82 and 83, another device 420 is shown. The end viewof FIG. 82 shows a plurality of loops 422 formed. The loops 422 areoriented at different positions relative to a longitudinal axis L of thedevice and may be angularly displaced as shown in FIG. 82. The loops areangularly displaced relative to one another by about 60-90 degreesrelative to the longitudinal axis L. The term loop as used herein doesnot necessarily mean that the elongate element forms a closed structurebut rather forms a loop-like structure when viewed from an end as shownin FIG. 82. The device 420 may have at least 3, 8 or 12 loops. Statedanother way, the device 420 may have about 6-40 loops. Similar to theother embodiments described above, the device 420 is held in thecollapsed position by a catheter or sheath 421 or other suitablestructure.

The loops 422 may be formed in any suitable manner. For example, theloops 422 may be formed by wrapping an elongate element 424, such as awire, around at least two mandrels (not shown). The elongate element 424is wound around the mandrels to form a repeating series of loops. Eachof the successive loops 422 may be formed by a different mandrel.Although each of the loops 422 may be formed by one mandrel, the loops422 may also be formed by more than one mandrel. The loops arerelatively elongate as shown in FIG. 83. The loops are generally helicaland may have an angle A of about 20-60 degrees so that they are somewhatstretched and elongate.

While the above is a description of the preferred embodiments of theinvention, various alternatives, substitutions and modifications may bemade without departing from the scope thereof, which is defined by thefollowing claims. Thus, the preferred embodiments should not be taken aslimiting the scope of the invention. For example, although all of theobstruction removal devices described herein are self-expandingstructures, the obstruction removal devices may also have actuatingmechanisms for moving the engaging element between the expanded andcollapsed positions. Furthermore, the present invention is directed to anumber of separate inventions and each of these inventions may beclaimed independently of one another. Each feature, aspect and advantageof the invention may be claimed independent of one another withoutdeparting from the scope of the invention. For example, use of the powersource 14 is independent of the using the intermittent wound sections 42but may be used with any of the devices and methods described herein. Asa further example, any engaging device, even a balloon, may be used withsome of the inventive aspects of the capture element and any captureelement may be used with inventive aspects of the engaging device.Finally, the devices of the present invention may also be used inconnection with simply controlling blood flow through an area and notnecessarily with removal of an obstruction.

1-121. (canceled)
 122. A method of removing an obstruction from a bloodvessel, comprising the steps of: providing an obstruction removingelement which is movable from a collapsed position to an expandedposition, the obstruction removing element having a first elongateelement and a second elongate element, the first and second elongateelements extending substantially parallel to one another and each beingmovable between a collapsed position and an expanded position;positioning the obstruction removing element in the collapsed position;advancing the obstruction engaging element into the obstruction; movingthe obstruction engaging element toward the expanded step out of thecatheter after the advancing step; and engaging the obstruction bymoving the obstruction engaging element after the advancing step. 123.The method of claim 122, wherein: the advancing step is carried out withthe first elongate element having an obstruction engaging portion, theobstruction engaging portion being advanced into the obstruction. 124.The method of claim 123, further comprising the steps of: advancing thesecond elongate element through the obstruction; expanding the secondelongate element at a position distal to the obstruction, the secondelongate element forming a trap which prevents the obstruction fromtraveling downstream.
 125. The method of claim 123, wherein: theproviding step is carried out with the first elongate element forming acoil when in the expanded position.
 126. The method of claim 125,wherein: the providing step is carried out with the coil formed by thefirst elongate element being wrapped around the second elongate elementwhen in the collapsed position.
 127. The method of claim 122, wherein:the first elongate element forms a coil configured to engage theobstruction when in the expanded position, the second elongate elementhaving a distal portion which forms a trap to prevent the obstructionfrom traveling downstream.
 128. The device of claim 122, wherein: thefirst and second elongate elements are longitudinally movable relativeto one another.
 129. A method of removing an obstruction from a bloodvessel, comprising the steps of: providing an obstruction removingdevice having a first obstruction removing element and a secondobstruction removing element, the first and second obstruction removingelements both being movable from a collapsed position to an expandedposition, the first and second obstruction removing elements beingindependently movable; positioning the obstruction removing device in atleast one catheter with the first and second obstruction removingelements in the collapsed position; advancing the catheter through theobstruction; moving the first obstruction engaging element out of thecatheter after the advancing step so that the obstruction removingelement moves toward the expanded position; expanding the secondobstruction removing element on an opposite side of the obstruction fromthe first obstruction engaging element so that the obstruction ispositioned between the first and second obstruction removing elements;and engaging the obstruction by moving at least one of the first andsecond obstruction removing elements.
 130. The method of claim 129,wherein: the providing step is carried out with the first and secondobstruction removing elements both being elongate elements which eachextend to a free end.
 131. The method of claim 129, wherein: theproviding step is carried out with first obstruction removing elementhaving a coiled shape extending to a free end.
 132. The method of claim129, wherein: the engaging step is carried out with the firstobstruction removing element engaging the obstruction while the secondobstruction removing element is positioned distal to the firstobstruction removing element to form a trap which prevents theobstruction from traveling downstream.
 133. The method of claim 129,wherein: the providing step is carried out with the first and secondobstruction removing elements being independently movable.
 134. Themethod of claim 129, wherein: the providing step is carried out with thefirst and second obstruction removing elements each extending through alumen in the same catheter.
 135. The method of claim 129, wherein: theengaging step is carried out with the first obstruction removing elementengaging the obstruction while the second obstruction removing elementis positioned downstream of the first obstruction removing element. 136.The method of claim 129, wherein: the engaging step is carried out withthe second obstruction removing element positioned distal to the firstobstruction removing element so that the second obstruction removingelement forms a trap to prevent the obstruction from travelingdownstream.
 137. A method for removing an obstruction from a bloodvessel, comprising the steps of: providing an obstruction removaldevice, the obstruction removal device having an obstruction engagingelement extending from an insertion element, the engaging element beingmovable from a collapsed condition to an expanded condition, theengaging element having a proximal portion and a distal portion; passingthe obstruction removal device through an obstruction in a vessel withthe engaging element in the collapsed position; expanding the distalportion at a location distal to the obstruction so that the distalportion forms a trap to prevent the obstruction from travelingdownstream; and engaging the obstruction with the proximal portion ofthe obstruction removal device after the expanding step.
 138. The methodof claim 137, wherein: the providing step is carried out with distalportion being independently movable relative to the obstruction engagingportion.
 139. The method of claim 138, wherein: the providing step iscarried out with the obstruction engaging portion forming a coilextending to a free end when in the expanded position.
 140. The methodof claim 138, wherein: the providing step is carried out with the distalportion being mounted to a first elongate element and the obstructionengaging element being mounted to a second elongate element, wherein theobstruction engaging portion is wrapped around the second elongateelement when in the collapsed position.
 141. The method of claim 140,wherein: the providing step is carried out with the first and secondelongate elements extending through the same catheter.